FDA Document Control Manager

We have a opening for a FDA Document Control Manager.

Must be able to work various shifts per week.

Manpower, Inc. of SE Michigan is currently seeking a part-time FDA document control manager to work for our client in Ann Arbor, MI. The selected candidate will oversee the medical device document change control process for FDA cGMP documentation requirements. This individual will also manage engineering change order process for establishing quality related documents, including the quality manual, quality management system SOPs, design history files, engineering drawings, device master records, device history files and manufacturing procedures required by the FDA Quality System Regulation (QSR - 21 CFR Part 820). Job duties include: * Maintaining document files to current requirements as defined by the FDA QSR and company quality system. * Processing documents for initial approval and revision changes. * Issuing approved and controlled documents to the appropriate locations. * Assisting in the development of the documentation as directed. * Maintaining the master document log and database. * Assisting in quality training of the company. * Assisting in maintaining the external standards and database. * Providing support to the quality assurance manager and R&D staff as needed. Preferred qualifications: * Bachelor's degree or equivalent experience. * Three to five years of document control experience in medical device industry. * Proficient in Microsoft Office, including Word, Excel, and Access. * Demonstrated experience with FDA regulations and engineering control processes. * Computer skills including word processing, spreadsheets and databases. * Strong written and verbal communication skills. * Good interpersonal skills. * Detail-oriented and organized. * Knowledge of company policies and procedures. * Ability to follow task through to completion. * Ability to perform assigned duties with minimal supervision. Manpower associates on assignment have access to a great benefit package including weekly paychecks, an insurance program, anniversary/holiday pay, training opportunities, direct deposit/paycard, tuition/certification reimbursement, and much more! Apply today or give us a call for more information: 734-665-3757 ext: 4. Want to get a head start? Go to www.manpowerjobs.com to create a "My Manpower" account, and then give us a call. Manpower, Inc. of SE Michigan has helped both companies and individuals navigate the ever-changing world of work in Washtenaw and Monroe Counties for over 50 years. To learn more, visit us at: http://www.manpowermi.com. Use social media? Like us! Follow us! * On Twitter: https://twitter.com/Manpowerincsemi * On Facebook: http://www.facebook.com/ManpowerIncofSEMich * On LinkedIn: http://www.linkedin.com/company/manpower-inc.-of-se-michigan * On Pinterest: http://www.pinterest.com/manpowerincsemi/ * On Instagram: http://instagram.com/manpowerincofsemi/ Know of others looking for work? Share this post! We reward those who refer successful associates. Ask us about our referral program. Manpower, Inc. of SE Michigan is an Equal Opportunity Employer.